Opioids in palliative care: safe and effective prescribing ... · Opioids in palliative care: safe...

Opioids in palliative care: safeand effective prescribing ofstrong opioids for pain inpalliative care of adults

Issued: May 2012

NICE clinical guideline 140guidance.nice.org.uk/cg140

NHS Evidence has accredited the process used by the Centre for Clinical Practice at NICE toproduce guidelines. Accreditation is valid for 5 years from September 2009 and applies to guidelinesproduced since April 2007 using the processes described in NICE's 'The guidelines manual' (2007,updated 2009). More information on accreditation can be viewed at www.evidence.nhs.uk

© NICE 2012

ContentsIntroduction .................................................................................................................................. 4

Drug recommendations........................................................................................................................... 5

Who this guideline is for .......................................................................................................................... 5

Patient-centred care ..................................................................................................................... 6

1 Recommendations .................................................................................................................... 7

Communication ....................................................................................................................................... 7

Starting strong opioids – titrating the dose .............................................................................................. 8

First-line maintenance treatment............................................................................................................. 8

First-line treatment if oral opioids are not suitable – transdermal patches .............................................. 9

First-line treatment if oral opioids are not suitable – subcutaneous delivery........................................... 9

First-line treatment for breakthrough pain in patients who can take oral opioids .................................... 9

Management of constipation ................................................................................................................... 10

Management of nausea .......................................................................................................................... 10

Management of drowsiness .................................................................................................................... 10

2 Notes on the scope of the guidance.......................................................................................... 12

3 Implementation ......................................................................................................................... 13

4 Research recommendations ..................................................................................................... 14

4.1 Communication ................................................................................................................................. 14

4.2 Side effects........................................................................................................................................ 14

4.3 Side effects........................................................................................................................................ 15

5 Other versions of this guideline ................................................................................................. 16

5.1 Full guideline ..................................................................................................................................... 16

5.2 NICE pathway ................................................................................................................................... 16

5.3 Information for the public................................................................................................................... 16

6 Related NICE guidance............................................................................................................. 17

Opioids in palliative care: safe and effective prescribing of strongopioids for pain in palliative care of adults

NICE clinicalguideline 140

© NICE 2012. All rights reserved. Last modified May 2012 of 24

7 Updating the guideline............................................................................................................... 18

Appendix A: The Guideline Development Group, National Collaborating Centre and NICEproject team.................................................................................................................................. 19

Guideline Development Group................................................................................................................ 19

National Collaborating Centre for Cancer ............................................................................................... 20

NICE project team................................................................................................................................... 20

Changes after publication............................................................................................................. 22

About this guideline ...................................................................................................................... 23




Introduction

Pain is common in advanced and progressive disease. Up to two-thirds of people with cancerexperience pain that needs a strong opioid. This proportion is similar or higher in many otheradvanced and progressive conditions.

Despite the increased availability of strong opioids, published evidence suggests that pain whichresults from advanced disease, especially cancer, remains under-treated.

Each year 300,000 people are diagnosed with cancer in the UK and it is estimated that there are900,000 people living with heart failure. Others live with chronic illness such as kidney, liver andrespiratory disease, and with neurodegenerative conditions. Many people with these conditionswill develop pain for which a strong opioid may be needed.

The 2008 World Cancer Declaration included a target to make effective pain control moreaccessible. Several key documents highlight the importance of effective pain control, including'Improving supportive and palliative care for adults with cancer' (NICE cancer service guidance2004), 'Control of pain in adults with cancer' (Scottish Intercollegiate Guidelines Networkguideline 106), 'A strategic direction for palliative care services in Wales' (Welsh AssemblyGovernment 2005) and 'End of life care strategy' (Department of Health 2008).

Strong opioids, especially morphine, are the principal treatments for pain related to advancedand progressive disease, and their use has increased significantly in the primary care setting.However, the pharmacokinetics of the various opioids are very different and there are markeddifferences in bioavailability, metabolism and response among patients. A suitable opioid must beselected for each patient and, because drug doses cannot be estimated or calculated inadvance, the dose must be individually titrated. Effective and safe titration of opioids has a majorimpact on patient comfort. The World Health Organization has produced a pain ladder for therelief of cancer pain; strong opioids are represented on the third level of the three-step ladder.

The guideline will address first-line treatment with strong opioids for patients who have beenassessed as requiring pain relief at the third level of the WHO pain ladder. It will not coversecond-line treatment with strong opioids where a change in strong opioid treatment is requiredbecause of inadequate pain control or significant toxicity.




http://www.who.int/cancer/palliative/painladder/en/

A number of strong opioids are licensed in the UK. However for pain relief in palliative care arelatively small number are commonly used. This guideline has therefore looked at the followingdrugs: buprenorphine, diamorphine, fentanyl, morphine and oxycodone. Misinterpretations andmisunderstanding have surrounded the use of strong opioids for decades, and these are onlyslowly being resolved. Until recently, prescribing advice has been varied and sometimesconflicting. These factors, along with the wide range of formulations and preparations, haveresulted in errors causing underdosing and avoidable pain, or overdosing and distressingadverse effects. Despite repeated warnings from regulatory agencies, these problems have ledon occasion to patient deaths, and resulted in doctors facing the General Medical Council orcourt proceedings. Additional guidance, including advice on reducing dosing errors with opioidmedicines, patient safety incidents arising from medication errors involving opioids and safer useof injectable medicines, is available from the National Patient Safety Agency (NPSA).

This guideline will clarify the clinical pathway and help to improve pain management and patientsafety. This guideline will not cover care during the last days of life (for example, while on theLiverpool Care Pathway).

Drug recommendations

The guideline assumes that prescribers will use a drug's summary of product characteristics toinform decisions made with individual patients.

Who this guideline is for

The target audience is non-specialist healthcare professionals initiating strong opioids for pain inadults with advanced and progressive disease. However, the guideline is likely to be of relevanceto palliative care specialists as well.




http://www.nrls.npsa.nhs.uk/

Patient-centred care

This guideline offers best practice advice on the care of people with advanced and progressivedisease, who require strong opioids for pain control. These patients are defined as those insevere pain who may be opioid-naive, or those whose pain has been inadequately controlled onstep two of the WHO pain ladder.

Treatment and care should take into account patients' needs and preferences. People withadvanced and progressive disease, who require strong opioids for pain control, should have theopportunity to make informed decisions about their care and treatment, in partnership with theirhealthcare professionals. If patients do not have the capacity to make decisions, healthcareprofessionals should follow the Department of Health's advice on consent and the code ofpractice that accompanies the Mental Capacity Act. In Wales, healthcare professionals shouldfollow advice on consent from the Welsh Government.

Good communication between healthcare professionals and patients is essential. It should besupported by evidence-based written information tailored to the patient's needs. Treatment andcare, and the information patients are given about it, should be culturally appropriate. It shouldalso be accessible to people with additional needs such as physical, sensory or learningdisabilities, and to people who do not speak or read English.

If the patient agrees, families and carers should have the opportunity to be involved in decisionsabout treatment and care.

Families and carers should also be given the information and support they need.




http://www.dh.gov.uk/en/DH_103643

http://www.dh.gov.uk/en/SocialCare/Deliveringsocialcare/MentalCapacity

http://www.dh.gov.uk/en/SocialCare/Deliveringsocialcare/MentalCapacity

http://www.wales.nhs.uk/consent

1 Recommendations

Communication

1.1.1 When offering pain treatment with strong opioids to a patient with advancedand progressive disease, ask them about concerns such as:

addiction

tolerance

side effects

fears that treatment implies the final stages of life.

1.1.2 Provide verbal and written information on strong opioid treatment to patientsand carers, including the following:

when and why strong opioids are used to treat pain

how effective they are likely to be

taking strong opioids for background and breakthrough pain, addressing:

how, when and how often to take strong opioids

how long pain relief should last

side effects and signs of toxicity

safe storage

follow-up and further prescribing

information on who to contact out of hours, particularly during initiation of treatment.

1.1.3 Offer patients access to frequent review of pain control and side effects.




Starting strong opioids – titrating the dose

1.1.4 When starting treatment with strong opioids, offer patients with advanced andprogressive disease regular oral sustained-release or oral immediate-releasemorphine (depending on patient preference), with rescue doses of oralimmediate-release morphine for breakthrough pain.

1.1.5 For patients with no renal or hepatic comorbidities, offer a typical total dailystarting dose schedule of 20–30 mg of oral morphine (for example, 10–15 mgoral sustained-release morphine twice daily), plus 5 mg oral immediate-releasemorphine for rescue doses during the titration phase.

1.1.6 Adjust the dose until a good balance exists between acceptable pain controland side effects. If this balance is not reached after a few dose adjustments,seek specialist advice. Offer patients frequent review, particularly in the titrationphase.

1.1.7 Seek specialist advice before prescribing strong opioids for patients withmoderate to severe renal or hepatic impairment.

First-line maintenance treatment

1.1.8 Offer oral sustained-release morphine as first-line maintenance treatment topatients with advanced and progressive disease who require strong opioids.

1.1.9 Do not routinely offer transdermal patch formulations as first-line maintenancetreatment to patients in whom oral opioids are suitable.

1.1.10 If pain remains inadequately controlled despite optimising first-linemaintenance treatment, review analgesic strategy and consider seekingspecialist advice.




First-line treatment if oral opioids are not suitable –transdermal patches

1.1.11 Consider initiating transdermal patches with the lowest acquisition cost forpatients in whom oral opioids are not suitable and analgesic requirements arestable, supported by specialist advice where needed.

1.1.12 Use caution when calculating opioid equivalence for transdermal patches:

A transdermal fentanyl 12 microgram patch equates to approximately 45 mg oralmorphine daily.

A transdermal buprenorphine 20 microgram patch equates to approximately 30 mgoral morphine daily.

First-line treatment if oral opioids are not suitable –subcutaneous delivery

1.1.13 Consider initiating subcutaneous opioids with the lowest acquisition cost forpatients in whom oral opioids are not suitable and analgesic requirements areunstable, supported by specialist advice where needed.

First-line treatment for breakthrough pain in patients whocan take oral opioids

1.1.14 Offer oral immediate-release morphine for the first-line rescue medication ofbreakthrough pain in patients on maintenance oral morphine treatment.

1.1.15 Do not offer fast-acting fentanyl as first-line rescue medication.

1.1.16 If pain remains inadequately controlled despite optimising treatment, considerseeking specialist advice.




Management of constipation

1.1.17 Inform patients that constipation affects nearly all patients receiving strongopioid treatment.

1.1.18 Prescribe laxative treatment (to be taken regularly at an effective dose) for allpatients initiating strong opioids.

1.1.19 Inform patients that treatment for constipation takes time to work andadherence is important.

1.1.20 Optimise laxative treatment for managing constipation before consideringswitching strong opioids.

Management of nausea

1.1.21 Advise patients that nausea may occur when starting strong opioid treatmentor at dose increase, but that it is likely to be transient.

1.1.22 If nausea persists, prescribe and optimise anti-emetic treatment beforeconsidering switching strong opioids.

Management of drowsiness

1.1.23 Advise patients that mild drowsiness or impaired concentration may occurwhen starting strong opioid treatment or at dose increase, but that it is oftentransient. Warn patients that impaired concentration may affect their ability todrive and undertake other manual tasks.

1.1.24 In patients with either persistent or moderate-to-severe central nervous systemside effects:

consider dose reduction if pain is controlled or

consider switching opioids if pain is not controlled.




http://www.dft.gov.uk/dvla/medical/ataglance.aspx

http://www.dft.gov.uk/dvla/medical/ataglance.aspx

1.1.25 If side effects remain uncontrolled despite optimising treatment, considerseeking specialist advice.




2 Notes on the scope of the guidance

NICE guidelines are developed in accordance with a scope that defines what the guideline willand will not cover.

How this guideline was developed

NICE commissioned the National Collaborating Centre for Cancer to develop this guideline.The Centre established a Guideline Development Group (see appendix A), which reviewedthe evidence and developed the recommendations.

There is more information about how NICE clinical guidelines are developed on the NICEwebsite. A booklet, 'How NICE clinical guidelines are developed: an overview forstakeholders, the public and the NHS' is available.




http://www.nice.org.uk/guidance/index.jsp?action=download&o=55374

http://publications.nice.org.uk/opioids-in-palliative-care-safe-and-effective-prescribing-of-strong-opioids-for-pain-in-palliative-cg140/appendix-a-the-guideline-development-group-national-collaborating-centre-and-nice-project-team

http://www.nice.org.uk/HowWeWork

http://www.nice.org.uk/aboutnice/howwework/developingniceclinicalguidelines/developing_nice_clinical_guidelines.jsp?domedia=1&mid=62F02D9B-19B9-E0B5-D4A26EC9A934FDC7

3 Implementation

NICE has developed tools to help organisations implement this guidance.




http://guidance.nice.org.uk/CG140

4 Research recommendations

The Guideline Development Group has made the following recommendations for research,based on its review of evidence, to improve NICE guidance and patient care in the future.

4.1 Communication

What are the most clinically effective and cost-effective methods of addressing patient and carerconcerns about strong opioids, including anticipating and managing adverse effects, andengaging patients in prescribing decisions?

Why this is important

We know from qualitative work that patients do not always understand how to take strong opioidsor the difference between sustained-release and rescue medication. Patients, their carers andsome clinicians fear the adverse effects of these drugs and believe that strong opioids, especiallymorphine, can be negatively associated with adverse effects and death. To improve adherenceand to enable patients and carers to benefit from the proven analgesic effects of strong opioids,research should be undertaken to determine how to address the main concerns of patients, thelevel of information they require and the best time and methods to deliver this. The benefits ofgreater involvement in this process by specialist nurses or pharmacists should also be examinedin research.

4.2 Side effects

Is prophylactic prescription of anti-emetic treatment or availability of anti-emetic treatment at thepatient's home more effective in reducing nausea than the availability of prescription on requestfor patients starting strong opioids for the treatment of pain in advanced or progressive disease?The outcomes of interest are nausea, time to control of nausea, patient acceptability oftreatment, concordance and use of healthcare resources.


Patients may experience transient nausea when starting opioid treatment and opioid-inducednausea often responds to anti-emetic treatment. When nausea occurs, timely review by ahealthcare professional to start anti-emetic treatment can be difficult to achieve in the community




setting. Prescription of routine anti-emetic treatment when starting opioids is controversial. It isimportant to evaluate the positive and negative impact of this strategy; while it may reduceopioid-induced nausea, improve adherence with opioid treatment, and reduce use of healthcareresources, the added burden to the patient and overall cost effectiveness are currently unclear.

4.3 Side effects

Is early switching of opioid, on development of side effects, more effective at reducing centralside effects than persisting with current opioid and dose reduction in patients starting strongopioids? The outcomes of interest are time to clinically effective pain control with acceptable sideeffects.


The common gastrointestinal opioid-induced side effects such as constipation or nausea canoften be managed with concomitant medications. A significant proportion of patients startingstrong opioids experience central side effects that patients report as distressing and often limitdaily activities. Although central side effects may be transient, persistent symptoms can bedifficult to treat and cause significant morbidity. The clinical strategy of opioid switching has beenshown to reduce central side effects. The impact of early switching, rather than dose reduction ora 'watch and wait' strategy has not been formally evaluated but may improve both time to opioidresponse and health-related quality of life.




5 Other versions of this guideline

5.1 Full guideline

The full guideline, Opioids in palliative care: safe and effective prescribing of strong opioids forpain in palliative care of adults, contains details of the methods and evidence used to developthe guideline. It is published by the National Collaborating Centre for Cancer.

5.2 NICE pathway

The recommendations from this guideline have been incorporated into a NICE pathway.

5.3 Information for the public

NICE has produced information for the public explaining this guideline.

We encourage NHS and voluntary sector organisations to use text from this information in theirown materials about strong opioids in advanced and progressive disease.




http://guidance.nice.org.uk/CG140/Guidance

http://guidance.nice.org.uk/CG140/Guidance

http://pathways.nice.org.uk/pathways/opioids-in-palliative-care

http://publications.nice.org.uk/IFP140

6 Related NICE guidance

Neuropathic pain: the pharmacological management of neuropathic pain in adults in non-specialist settings. NICE clinical guideline 96 (2010).

Chest pain of recent onset: assessment and diagnosis of recent onset chest pain ordiscomfort of suspected cardiac origin. NICE clinical guideline 95 (2010).

Low back pain: early management of persistent non-specific low back pain. NICE clinicalguideline 88 (2009).

Rheumatoid arthritis: the management of rheumatoid arthritis in adults. NICE clinicalguideline 79 (2009).

Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin. NICE technologyappraisal 159 (2008).

Metastatic spinal cord compression: diagnosis and management of adults at risk of and withmetastatic spinal cord compression. NICE clinical guideline 75 (2008).

Osteoarthritis: the care and management of osteoarthritis in adults. NICE clinical guideline59 (2008).

Improving supportive and palliative care for adults with cancer. NICE cancer serviceguidance (2004).




http://www.nice.org.uk/guidance/CG96






http://www.nice.org.uk/guidance/TA159




http://www.nice.org.uk/CSGSP

7 Updating the guideline

NICE clinical guidelines are updated so that recommendations take into account important newinformation. New evidence is checked 3 years after publication, and healthcare professionalsand patients are asked for their views; we use this information to decide whether all or part of aguideline needs updating. If important new evidence is published at other times, we may decideto do a more rapid update of some recommendations. Please see our website for informationabout updating the guideline.




Appendix A: The Guideline Development Group, NationalCollaborating Centre and NICE project team

Guideline Development Group

Damien Longson (Chair)Consultant Liaison Psychiatrist and Honorary Senior Lecturer, University of Manchester

Catherine StannardConsultant in Pain Medicine, Frenchay Hospital, Bristol

Mike BennettSt Gemma's Professor of Palliative Medicine, University of Leeds

Catherine PigginLead Clinical Nurse Specialist, Prospect Hospice, Swindon

Lindsay SmithGeneral Practitioner, Somerset

Joy RossConsultant in Palliative Medicine, Royal Marsden & Royal Brompton NHS Foundation Trusts,London

Mark TaubertConsultant in Palliative Medicine, Marie Curie Centre Penarth & Velindre NHS Trust, Cardiff

Margaret GibbsSenior Specialist Pharmacist, St Christopher's Hospice, London

Anna-Marie StevensMacmillan Nurse Consultant Cancer Palliative Care, Royal Marsden NHS Trust, London

Natalie LainePatient and carer member




Vivien PipePatient and carer member

National Collaborating Centre for Cancer

John GrahamDirector

Andrew ChampionCentre Manager

Angela BennettAssistant Centre Manager

Katrina Asquith-CoeProject Manager

Mia Schmidt-HansenResearcher

Catrin LewisResearcher

Stephanie ArnoldInformation specialist

Huajie JinHealth Economist

Matthew PrettyjohnsHealth Economist

NICE project team

Judith RichardsonAssociate Director




Claire TurnerGuideline Commissioning Manager

Anthony GildeaGuideline Coordinator

Judith ThorntonTechnical Lead

Michelle Wallwin, Sarah CatchpoleEditors




Changes after publication

October 2012 : Minor maintenance




About this guideline

NICE clinical guidelines are recommendations about the treatment and care of people withspecific diseases and conditions in the NHS in England and Wales.

The guideline was developed by the National Collaborating Centre for Cancer, which is based atthe Velindre NHS Trust. The Collaborating Centre worked with a group of healthcareprofessionals (including consultants, GPs and nurses), patients and carers, and technical staff,who reviewed the evidence and drafted the recommendations. The recommendations werefinalised after public consultation.

The methods and processes for developing NICE clinical guidelines are described in Theguidelines manual.

The recommendations from this guideline have been incorporated into a NICE Pathway. Wehave produced information for the public explaining this guideline. Tools to help you put theguideline into practice and information about the evidence it is based on are also available.

Your responsibility

This guidance represents the view of NICE, which was arrived at after careful consideration ofthe evidence available. Healthcare professionals are expected to take it fully into account whenexercising their clinical judgement. However, the guidance does not override the individualresponsibility of healthcare professionals to make decisions appropriate to the circumstances ofthe individual patient, in consultation with the patient and/or guardian or carer, and informed bythe summary of product characteristics of any drugs they are considering.

Implementation of this guidance is the responsibility of local commissioners and/or providers.Commissioners and providers are reminded that it is their responsibility to implement theguidance, in their local context, in light of their duties to avoid unlawful discrimination and to haveregard to promoting equality of opportunity. Nothing in this guidance should be interpreted in away that would be inconsistent with compliance with those duties.

Copyright




http://www.nice.org.uk/aboutnice/howwework/developingniceclinicalguidelines/clinicalguidelinedevelopmentmethods/clinical_guideline_development_methods.jsp

http://www.nice.org.uk/aboutnice/howwework/developingniceclinicalguidelines/clinicalguidelinedevelopmentmethods/clinical_guideline_development_methods.jsp

http://pathways.nice.org.uk/pathways/opioids-in-palliative-care

http://publications.nice.org.uk/IFP140


© National Institute for Health and Clinical Excellence 2012. All rights reserved. NICE copyrightmaterial can be downloaded for private research and study, and may be reproduced foreducational and not-for-profit purposes. No reproduction by or for commercial organisations, orfor commercial purposes, is allowed without the written permission of NICE.

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